CN107091870A - Determine measurement apparatus, bio-sensor system and the method for analyte concentration - Google Patents

Determine measurement apparatus, bio-sensor system and the method for analyte concentration Download PDF

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CN107091870A
CN107091870A CN201710080974.9A CN201710080974A CN107091870A CN 107091870 A CN107091870 A CN 107091870A CN 201710080974 A CN201710080974 A CN 201710080974A CN 107091870 A CN107091870 A CN 107091870A
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sample
pulse
excitation pulse
measurement apparatus
programmed
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CN107091870B (en
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伍焕平
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Bayer Healthcare LLC
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Bayer Healthcare LLC
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3273—Devices therefor, e.g. test element readers, circuitry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems

Abstract

The present invention discloses for determining the sensing system of analyte concentration, apparatus and method in sample.Sample will be inputed to including the input signal with continuous agitation pulse and multiple work periods of relaxation.One or more signals from sample output in the 300ms of input excitation pulse can be made associated with the analyte concentration of sample, to improve the degree of accuracy and/or the precision of analysis.The output valve measured rapidly according to these determines that the analyte concentration of sample can reduce the analytical error caused by hematocrit effect, medium back end and other error sources.

Description

Determine measurement apparatus, bio-sensor system and the method for analyte concentration
It is on October 23rd, 2008, the application number of entitled " rapid-read gated amperometry " applying date that the application, which is, For the divisional application of 200880120045.5 patent application.
Background technology
Biology sensor is provided to biofluid (such as whole blood, serum, blood plasma, urine, saliva, iuntercellular or cell Interior liquid) means analyzed.Generally, biology sensor has the measurement dress for being used for analyzing the sample resided on sensing zone Put.The sample is in generally liquid form, and in addition to for biofluid, can also be the derivative of biofluid, for example Extract, dilution, filtrate or restructuring sediment.One or more analytes are determined in the analysis carried out by biology sensor (such as alcohol, glucose, uric acid, lactic acid, cholesterol, bilirubin, free fatty acids, triglycerides, protein, ketone, phenyl third Propylhomoserin or enzyme) presence in biofluid and/or concentration.The analysis can aid in physically different diagnosis and treatment. For example, diabetes patient can use biology sensor to determine the glucose level in whole blood to adjust food and/or medicine.
Biology sensor can be designed as analyzing one or more analytes, and can use different samples Amount.Some biology sensors can analyze single drop whole blood of such as volume for 0.25-15 microlitres (μ L).Can be using desk-top, just Take formula and similar measurement apparatus realizes biology sensor.Portable type measurement unit can be hand-held, can be in sample One or more analytes be identified and/or quantitative analysis.The example of Portable type measurement unit includes New York Ta Lidun (Tarrytown) Ascensia of Bayer HealthCare companiesWithMeter, desk-top measurement dress The example put includes what can be bought from the CHInstruments companies of Texas, USA (Texas) Austin (Austin) Electrochemical workstation (Electrochemical Workstation).Analysis time is shorter to be provided simultaneously with the desired degree of accuracy And/or the biology sensor of accuracy can bring huge benefit to user.
Biology sensor can analyze sample using optics and/or electrochemical method.In some optical systems, pass through Measure with can light identification material (such as analyte, reactant or the product formed by chemical indicator and analyte response) The light of interaction determines analyte concentration by the light of the material absorbing.In other optical systems, chemical indicator exists Fluoresce or light according to analyte when being irradiated by excitation beam.The light can be transformed into electrical output signal (for example electric current or Voltage), the light again may be by electrochemical method and be processed into output signal.In any optical system, biology sensor Light is measured and is allowed to associated with the analyte concentration of sample.
In electrochemica biological sensor, when input signal is applied into sample, according to by analyte or with this point The electric signal that the oxidation/reduction or redox reaction of the corresponding material of analysis thing are produced determines analyte concentration.Input signal can To apply as individual pulse, multiple pulses, sequence or cycle ripple.Oxidoreducing enzyme (such as enzyme or the like) can be added Enter into sample, to improve during redox reaction from the first material to the electron transfer of the second material.Enzyme or the like Matter can be reacted with single analyte, therefore provide specificity to a part for produced output signal.In table 1 below Give the example of some specific oxidoreducing enzyme and corresponding analyte.
Table 1
Oxidoreducing enzyme (reagent layer) Analyte
Glucose dehydrogenase β-glucose
Glucose oxidase β-glucose
Cholesterol esterase；Cholesterol oxidase Cholesterol
Lipoprotein lipase；Glycerokinase；Glycerol-3-phosphate oxidase Triglycerides
LO；Lactic dehydrogenase；Diaphorase Lactic acid
Pyruvate oxidase Acetonate
Alcohol oxidase Alcohol
Bilirubin oxidase Bilirubin
Uricase Uric acid
Glutathione reductase NAD(P)H
Oxidation of Carbon Monoxide reductase Carbon monoxide
The state of oxidation of enzyme can be kept using medium.Table 2 below gives the enzyme and medium for making a concrete analysis of thing Some of thing are routinely combined.
Table 2
Electrochemica biological sensor generally includes the measurement apparatus with the electric contact being connected with the wire in sensing zone.This A little wires can be made up of the conductive material such as solid metal, metal paste, conductive carbon, conductive carbon paste, conducting polymer.Wire Generally it is connected with the working electrode extending into sample container, counter-electrodes, reference electrode and/or other electrodes.One or many Root wire can also extend into sample container that there is provided the function that these electrodes are not provided.
In many biology sensors, sensing zone can be used for that biological tissue is outside, internal or partial interior.For living When outside body tissue, biological fluid sample is imported into the sample container in sensing zone.Before analysis sample is imported, afterwards Or period, sensing zone is placed in measurement apparatus.Inside for biological tissue or during partial interior, sensing zone can be connected Sample in the sample, or intermittently can be imported on sensing zone by continuous immersion.Sensing zone can include container, and the container is used Partly to isolate the sample of certain volume or lead to sample.Equally, during sample can continuously flow through sensing zone or be allowed to Break to analyze.
Measurement apparatus applies input signal by electric contact to the electric wire of sensing zone.Electric wire is defeated by input signal by electrode It is sent in the sample in sample container.The redox reaction of analyte produces electrical output signal according to input signal.Carry out autobiography Feel the electrical output signal of band (can pass through potential measurement for electric current (being produced by amperometry or Voltammetry), voltage Method/amperometry is produced) or accumulation electric charge (being produced by method of coulometric analysis).Measurement apparatus can have measurement biological The presence of one or more analytes and/or concentration and make its disposal ability associated with output signal in liquid.
In common amperometric, the working electrode of sensing zone is applied in the reading pulse of constant potential (voltage) With in counter-electrodes during measure electric current, measured electric current is used for determining the amount of analyte in sample.Amperometric is surveyed The speed that amount electrochemistry is active thus measurable material is aoxidized or reduced at working electrode or near it.For example it is special in the U.S. The amperometric for biology sensor is described in sharp US5620579, US5653863, US6153069 and US6413411 Many modifications.
The shortcoming of common current mensuration is the Unsteady characteristics of the electric current after current potential is applied.Electric current is relative to the time Pace of change it is very fast at the beginning, can be carried out caused by the variation characteristic of potential diffusion process with analysis and slack-off.Directly Depletion rate to the measurable material ionized at electrode surface is equal to diffusion velocity, could obtain steady-state current.Therefore, The common current mensuration of electric current is measured during the transition period before reaching stable situation not as entering during stable state period The accuracy of row measurement is high.
The measurement performance of biology sensor is presented as the degree of accuracy and/or precision.The degree of accuracy and/or the raising of precision can be carried The measurement performance of high biology sensor.The degree of accuracy can be with biosensor analysis thing reading relative to reference analyte reading Deviation represents that deviation is bigger to represent that the degree of accuracy is lower, and precision can be with multiple analyte readings relative to average value It is discrete or change and represent.Deviation is the difference between the numerical value that biology sensor is determined and generally acknowledged reference value, can be with " absolutely To deviation " or " relative deviation " represent.Absolute deviation can represent that relative deviation can with the units of measurement such as mg/dL To be expressed as percentage of the absolute deviation values relative to reference value.Reference value can (for example can be from YSI with master meter Inc., the STAT PLUS of YSI 2300 that Yellow Springs, Ohio. are boughtTM) obtain.
Many biology sensors include one or more methods to correct the error related to analysis.According to error It is inaccurate to analyze obtained concentration value.These inaccurate assay values, which can be corrected, can just improve acquired concentration value The degree of accuracy.Error correcting system can compensate one or more errors, such as sample hematocrits different from reference coupon Content.For example, common biology sensor can be configured to the grape that report assumes 40% (V/V) hematocrit of whole blood sample Sugared concentration, and it is unrelated with the actual hematocrit of sample.In such systems, with less than or greater than 40% haemocyte ratio Any glucose measurement carried out on the whole blood sample of appearance will include the error or deviation for being attributable to " hematocrit effect ".
In the common biological sensing zone for determining concentration of glucose, by enzyme grape can be made glycoxidative, made afterwards Electro transfer is obtained to medium.The medium of the reduction is then transferred on working electrode, there by electrochemical oxidation.Can So that the amount of oxidized medium is related to the electric current between the working electrode and counter-electrodes of sensing zone.In amount, Diffusion coefficient of the electric current measured at working electrode directly to medium is proportional.Hematocrit effect hinders the process, Because red blood cell hinders diffusion of the medium to working electrode.Therefore, hematocrit effects are at working electrode The magnitude of current of measurement, and there is no any relation with the glucose amount in sample.
Hematocrit bias refers to that be directed to the sample with different hematocrit levels obtains with reference instrument Reference concentration of glucose and the experiment glucose readings that are obtained by biology sensor between difference.In reference value and by biology Difference between the numerical value that sensor is obtained is due to different hematocrit levels between specific whole blood sample and caused 's.
In addition to hematocrit effect, when measurable material concentration is uncorrelated to analyte concentration, also occur Measurement is inaccurate.For example, during the concentration for the reduction medium determined analyte oxidation in sensing system and produced, due to matchmaker Jie's thing back end, is not that as any reduction medium produced by analyte oxidation reaction sensing system will be caused to show in sample In the presence of analytes more more than accurate picture.Therefore, " medium back end " is because measurable material is dense not with inherent analyte Degree corresponds to and caused the deviation being incorporated into measured analyte concentration.
When attempting to overcome one or more of these shortcomings, common biology sensor has had attempted to multiple technologies, These technologies not only for sensing zone Machine Design, and further relate to measurement apparatus to sensing zone apply current potential mode.Example Such as, for reduce amperometric sensor hematocrit effect commonsense method including the use of wave filter, such as in United States Patent (USP) Disclosed in US5708247 and US5951836；So that the current polarity reversion applied, such as the institute in WO2001/57510 As disclosure；And by causing the maximum method of the inherent resistance of sample.
The a variety of of input signal are applied to sensing zone using commonly known as pulse method, serial method or round-robin method Method is come the inaccuracy of analyte concentration determined by solving.For example, in United States Patent (USP) US4897162, input signal bag The raising and lowering voltage potential continuously applied is included, they, which are mixed, provides triangular waveform.In addition, WO2004/053476, United States Patent (USP) US2003/0178322 and US2003/0113933 are disclosed including the continuous raising and lowering for applying change in polarity The input signal of voltage potential.
Special electrodes structure is combined by other commonsense methods with the input signal suitable for the structure.For example, the U.S. Patent No.5942102 combines the special electrode structure formed by thin layer element and continuous impulse, so that from pairing The reaction product of electrode reaches working electrode.The combination be used for drive reaction, until electric current change over time it is constant untill, therefore The medium moved during current potential step between working electrode and counter-electrodes reaches true steady state situation.Although these sides Each in method balances various merits and demerits, but all undesirable.
It can be seen from the above description that have always a demand for improving biology sensor at present, especially can be in the shorter time The inside more accurate biology sensor for determining analyte concentration.The systems, devices and methods of the present invention overcome conventional system and deposited At least one shortcoming.
The content of the invention
The invention provides a kind of method for determining analyte concentration in sample, this method comprises the following steps：To sample Apply input signal, the input signal included at least three work period in 10 seconds, wherein each work period includes exciting Pulse and relaxation；Measurement is corresponding with measurable material in 300 milliseconds of the application excitation pulse of at least one work period Output signal；The concentration of analyte in sample is determined according to measured output signal.Each of these work periods can wrap Can exciting and relaxation with the fixed potential of record current during including.Pulse train can include terminal read pulse, Ke Yishi It is added on the sensing zone including diffusion impervious layer.With there is no output signal to measure identical or other method phase in 300 milliseconds Than deviation of the identified analyte concentration caused by medium back end is smaller.By using transient current data, defeated During entering the excitation pulse of signal work period in no arrival stable situation, it may be determined that go out the concentration of analyte.Can be with Data processing is carried out to measured electric current, for determining the analyte concentration in sample.
It is set to for the handheld measuring device of receiving sensing zone for determining the analyte concentration in sample.The device The circuit of electrical connection is set up including contact, at least one display and between contact and display.The circuit includes charger And processor, wherein processor electrically connects with storage medium.The storage medium includes computer readable software code, these codes Charger is caused to perform the input including at least three work period in 10 seconds between contacts and believe when by computing device Number.Each work period includes exciting and relaxation.Processor can be used for applying in charger to be measured extremely in 300 milliseconds excited At least one current value at few two contacts.Processor may further be used to be determined in biofluid according at least one current value Analyte.
The invention provides a kind of bio-sensor system for being used to determine analyte concentration in sample.The system includes： Sensing zone with the adjacent sample interface of the container with being formed by sensing zone, and with the processing being connected with sensor interface The measurement apparatus of device.Sensor interface is electrically connected with sample interface, and processor is electrically connected with storage medium.Processor is to sample Interface, which applies, determines output letter corresponding with analyte concentration in sample from sensor interface in 300 milliseconds of excitation pulse Number value.Excitation pulse is included a part for the input signal of at least three work period in 10 seconds, and each work period includes Excite and relaxation.
It is used to reduce due to the hematocrit effect of analyte concentration in identified sample present invention also offers a kind of The method of deviation caused by answering, this method includes being applied in 10 seconds the input letter including at least three work period to sample Number.The output signal for determining analyte concentration institute foundation in sample is recorded in apply excitation pulse 300 milliseconds.
Brief description of the drawings
The present invention is will be better understood when with reference to following drawing and description.All parts in the drawings need not be by Ratio is drawn, it is preferred that emphasis is illustrate the principle of the present invention.
Fig. 1 shows the electrochemical analysis method for determining the presence of analyte and/or concentration in sample.
Fig. 2 is curve map, shows the output signal that the input signal measured according to gating current is produced.
Fig. 3 A show each in three current values measured from each pulse of seven pulses shown in Fig. 2 Hematocrit bias present in analyte concentration value determined by individual.
Fig. 3 B show the hematocrit bias scope of the sample including 50,100 and 400mg/dL glucose.
Fig. 4 show for multiple whole blood samples in Fig. 3 A P5 first and the 3rd current value hematocrit Deviation.
Fig. 5 shows the schematic diagram for determining the biology sensor of analyte concentration in sample.
Embodiment
" in Gated Amperometry " WO2007/013915, examination is analyzed using pulse input signal entitled Analyte in sample.Input signal includes alternate excitation cycle and relaxaton period.The present invention relates to according to pulse input signal Output signal is analyzed to reduce for example due to the system and method for deviation caused by medium back end and hematocrit effect. Association is set up by the output signal value that will be measured in the 300ms at the beginning of excitation pulse, the accurate of analysis can be improved Degree and/or precision.
Fig. 1 shows the electrochemical analysis method 100 for determining the presence of analyte and/or concentration in sample.In step In rapid 110, introduce a sample into biology sensor.In the step 120, a part of analyte in sample carries out redox Reaction.In step 130, it is transferred to medium from analyte to electronic selection.In step 140, input signal electrochemistry is used Excite measurable material.In step 150, produce output signal and it is measured.In a step 160 so that sample Relaxation, in step 170, inputs other excitation pulse.In step 180, analyte in sample is determined according to output signal Presence and/or concentration, in step 190, the concentration is shown, stored.
In step 110, the Sensor section (such as sensing zone) of biology sensor is introduced a sample into.Sensing zone includes At least one working electrode and at least one counter-electrodes.These electrodes can include one or more reagent layers.Working electrode The diffusion impervious layer integrally or with reagent layer separated with reagent layer can be included.Include separated diffusion in working electrode to hinder During barrier, reagent layer may be not necessarily provided on diffusion impervious layer.
Diffusion impervious layer is provided with porous space, and the porous space, which has, can allow the inside that measurable material is resided therein Volume.The hole of diffusion impervious layer can be selected so that measurable material can be spread in diffusion impervious layer, and by volume Larger sample construct (such as red blood cell) is substantially excluded.Come although common sensing zone has employed various materials from work Red blood cell filtration is fallen in the surface for making electrode, but diffusion impervious layer provides internal porous space and come to include and isolate A part of measurable material of sample.It can be seen that diffusion impervious layer in U.S. Patent Publication text No.2007/0246357 Be described in more detail.
In Fig. 1 step 120, a part of analyte for for example to be present in sample by oxidoreducing enzyme is carried out Chemistry or biochemical oxidation or reduction, this is due to sample carry out hydration reaction with reagent caused by.One occurs oxidation instead Answer or reduction reaction, electronics just can be shifted selectively between analyte and medium in step 130.Thus, for example The measurable material of ionization is formed by analyte or medium.Preferably reagent provides initial time delay with analyte response Or " latent (incubation) ".Preferably, the initial time delay can be 1 to 10 second.In United States Patent (USP) US5620579 With in US5653863 it can be seen that initial time delay is described in more detail.
In Fig. 1 step 140, (oxidation is reduced) measurable material is excited using input signal electrochemistry, this can be surveyed Quantity of material can be the electrically charged analyte from step 120 or the electrically charged medium from step 130.Input signal can be with For pulse or with setting the electric signal (such as electric current or current potential) for connecting in turn and disconnecting.Input signal be by relaxation every The excitation pulse sequence opened.During current measurement pulse, the current potential applied during exciting period its whole duration preferably with The voltage and polarity of substantial constant apply.This commonly excites to be formed and directly compareed with some, in data note in common excite Voltage changes or " after (swept) " multiple voltage potentials and/or polarity during record.
During relaxation, electric signal disconnects.Disconnecting includes the period in the absence of electric signal, does not preferably include the presence of electric signal But there is no the period of any amplitude.Electric signal can switch on and off it by closing and opening circuit respectively Between switch.Circuit can be closed and open using mechanical means, electrical method or other methods.
Input signal can have one or more pulse spacings.Pulse and relaxation of the pulse spacing for the composition work period Summation.Each pulse has amplitude and width.Amplitude represents the intensity of the current potential of electric signal, electric current etc..Amplitude is for example in electricity Can be change or substantial constant during flow measurement, during pulse.Pulse width is the duration of pulse.Input letter Number pulse width can be change or it is substantially the same.Each relaxation has relaxation width, this be relaxation it is lasting when Between.The relaxation width of input signal can be change or substantially the same.
By the width excited with relaxation in adjustment work cycle, gate input signal can improve the degree of accuracy of analysis And/or precision.While not wishing to constrained by any particular theory, but the degree of accuracy and/or the raising of precision are from expansion Extract the result for the measurable material being stimulated at working electrode in the inside for dissipating barrier layer.With due to red blood cell and other sample groups Measurable material outside the diffusion impervious layer of diffusion velocity into thing with change is on the contrary, surveying in diffusion impervious layer Quantity of material has the diffusion velocity of relative constancy to conductor.For example, such as in entitled " Concentration Determination in a Diffusion Barrier Layer " U.S. Patent Publication text No.2007/0246357 Described in it is the same, diffusion impervious layer can be substantially limited to so that measurable material to be excited with strobe pulse width.
It is preferred that input signal include at least 3 applied less than 30, during 10 or 5 seconds, 4,6,8 or 10 work week Phase.It is further preferred that applying at least three work period in 10 seconds.It is included in less than 7 seconds and applies at least four work period Input signal at present particularly preferably.Preferably, the width of each excitation pulse is independently selected from 0.1~2 second, is more preferably selected From 0.2~1 second.At present, particularly preferably, input signal pulse width is independently selected from 0.3~0.8 second.It is preferred that pulse between It is interposed between less than 3, in the range of 2.5 or 1.5 seconds.At present, the pulse with the pulse width of 0.3 to 0.5 second and from 0.7 to 2 second The input signal at interval is particularly preferably.Input signal can also have other pulse widths and interval.
In Fig. 1 step 150, biology sensor produces output signal according to measurable material and input signal.Output Signal (such as one or more current values) can be measured continuously or intermittently, can also be recorded as the function of time Come.Output signal can include signal, the signal that first then increase declines, the signal for reaching stable state and the wink declined at the very start When signal.It can be observed in change substantial constant (such as in ± 10% or ± 5%) of electric current relative to the time steady State electric current.Instead of the electric current of common stable state or slow-decay, it can be obtained instantaneously (rapid decay) according to pulse input signal Current value.
Fig. 2 is curve map, shows and measures the output signal that input signal is produced according to gating current.It is being depicted as the time Function when, each excitation pulse cause initial high current value decay transient attenuation curve.For seven work periods altogether For, the input signal applied by biology sensor includes eight pulses and seven relaxation.Fig. 2 eliminated for the first work period, Show behind the 8th pulse there is no relaxation.Pulse is applied with about 200mV, pulse width is about 0.4 second.Work period Pulse spacing be about that there is provided the relaxation width of about 1 second in 1.4 seconds.Relaxation is provided by dead circuit.Although employing Square-wave pulse, but can also be using the other waveforms for being adapted to sensing system and test sample.
Output signal is intermittently measured during each pulse of biology sensor in fig. 2, and three current values are remembered Record is in the storage device.After each pulse about 125ms, recorded and exported with the interval of about 125 milliseconds (ms) Signal value.Interval between continuous record can be with identical or different.In fig. 2, three current values from output signal are recorded And identified with letter i, pulse sequence number and measurement sequence number are represented with subscript.Therefore, the 3rd current value measured for the 5th pulse It is designated as i5,3。
Fig. 3 A show each institute according to three current values measured from each of seven pulses shown in Fig. 2 Hematocrit bias present in the analyte concentration value of determination, the bigger expression hematocrit of absolute value in Y-axis is missed Difference is bigger.For each pulse, the first current value shows the minimum hematocrit bias of three numerical value, and the first He Deviation between third value becomes much larger with each succeeding impulse.For each succeeding impulse, it can be observed surveyed Lower average blood cell specific-volume anomaly on the electric current of amount；But, each additional pulse extension analysis time length.Cause This, although the current value from P8 hardly includes any hematocrit error, but the first current value from P5 can be with There is provided in hematocrit error and between analysis time preferred balance.It is further noted that measured for P5 first Current value has the hematocrit error about the same with the 3rd current value of the P8 from subsequent more than three seconds.These results Show, the forward current value measured includes minimum hematocrit error in pulse width.
Fig. 3 B show the hematocrit bias scope of the sample including 50,100 and 400mg/dL glucose, in Y-axis On range values it is bigger represent hematocrit error it is bigger.As shown in Figure 3A, the first current value shows in each pulse period Between the minimum hematocrit bias of four current values measured, in the deviation of first and the 4th between numerical value with each follow-up arteries and veins Rush and become much larger.The unexpected low hematocrit bias of the first current value gone out for each impulsive measurement is higher 400mg/dL concentration of glucose levels under become apparent.Therefore, by with whole blood sample concentration of glucose increase and Current measurement is carried out in the decay of increase as early as possible to improve the degree of accuracy.
Fig. 4 is shown for including the hematocrit of change and multiple whole blood samples of glucose content from Fig. 3 A's P5 first and the 3rd current value hematocrit bias.First current value i5,1Show R2Correlation is 0.18, the 3rd electricity Flow valuve i5,3Show R2Correlation is 0.08, reduces more than 50%.Obtained from the current value obtained in early days from decay The higher analyte concentration degree of accuracy is unexpected, is formed and directly compareed with prior art, and prior art is from decay Behind the measured value that obtains in steady-state portion realize the degree of accuracy.These results indicate that according to the wink of the rapid change of decay When part in the measurement result that obtains in early days can realize the higher degree of accuracy and/or precision.
Preferably, the output electricity that measurement in 300ms determines analyte concentration institute foundation that is less than of excitation pulse is being applied Flow valuve.It is further preferred that since the output current value of the analyte concentration for determining sample be less than applying excitation pulse It is measured in 175ms or in apply pulse 10 to 150ms.It is even more preferred that, determine the output electricity of concentration institute foundation Flow valuve is measured in apply excitation pulse 30 to 150ms.At present, surveyed according in apply excitation pulse 60 to 150ms The output current value gone out determines analyte concentration particularly preferably.Preferably, analyte output current value is therefrom measured to determine The pulse of analyte concentration applies in 11 seconds that apply initial excitation pulse or shorter time in sample, is more preferably applying just 7 seconds of initial pulse or the interior application of shorter time.
In Fig. 1 step 160, sample experience relaxation.Measurement apparatus can be by sensing zone disconnecting circuit, therefore allows Relaxation.During the relaxation of step 160, the electric current for exciting period presence of step 140 substantially reduces at least half, preferably drops Order of magnitude lower, is more preferably reduced to zero.Preferably, by its known to disconnecting circuit or those of ordinary skill in the art There is provided the electric current being substantially zero to realize zero current condition for its method.Preferably, do not remember during the relaxation of step 160 Record output signal.
During the relaxation of step 160, ion agent (such as oxidoreducing enzyme) can not have with analyte response Current potential produces extra measurable material in the case of influenceing.E.g., including glucose oxidase as reagent and iron cyaniding The glucose biological sensor of thing medium is produced and sample during the relaxation of step 160 in the case where not disturbed by current potential The corresponding extra ferrocyanide (reduction medium) of analyte concentration.
In Fig. 1 step 170, biology sensor continues that the pulse from input signal is applied into working electrode and matched somebody with somebody To the electrode stipulated time.The work period of the relaxation period of stimulating phase and step 160 including step 140 can repeat, Huo Zheke To apply the work period with different pulse widths and/or interval.
In Fig. 1 step 180, the output signal value that biosensor analysis is recorded in the 300ms for applying pulse To determine the analyte concentration in sample.Other electric currents, time and/or other values can also be analyzed.In step 190, may be used To show, store the analyte concentration value, for reference in future and/or for other calculating.
Fig. 5 shows using pulse input signal to determine the biology sensor of the analyte concentration in biological fluid sample 500 schematic diagram.Biology sensor 500 includes measurement apparatus 502 and sensing zone 504, and the biology sensor can be realized to be any Analytical instrument, including bench device, portable or portable equipment etc..It is dense that biology sensor 500 may be used to determine analyte Degree, includes the concentration of glucose, uric acid, lactic acid, cholesterol, bilirubin etc..Although showing specific structure, biology is passed Sensor 500 can also have other structures, including those structures with additional component.
Sensing zone 504 has substrate 506, the substrate 506 formation container 508 and the passage 510 with opening 512.Container 508 Can be with the porose cap covers of apparatus with passage 510.Container 508 defines partially enclosed space.Container 508 can include Help keep liquor sample component, for example can water swelling polymer or porous polymer matrix.Reagent can be contained It is placed in container 508 and/or passage 510.Reagent can include the materials such as one or more enzymes, bonding agent, medium.Sensing zone 504 can also have the sample interface 514 being arranged near container 508.The sample interface 514 can be partially or fully enclosed Container 508.Sensing zone 504 can also have other structures.
Sample interface 514 has the wire being connected with working electrode and counter-electrodes.These electrodes can be lain substantially in In identical plane or in more than one plane.Other spacing distances can also be used between electrode and lid. These electrodes can be arranged on the surface for the substrate 506 to form container 508.Electrode extends to or extend into container 508 In.Dielectric layer can partly cover wire and/or electrode.Sample interface 514 can also have other electrodes and wire.
Measurement apparatus 502 includes the circuit 516 being connected with sensor interface 518 and display 520.Circuit 516 include with The processor 522 that signal generator 524, optional temperature sensor 526 and storage medium 528 are connected.
Signal generator 524 provides electrical input signal in response to processor 522 to sensor interface 518.Electrical input signal Sample interface 514 can be sent to from sensor interface 518 to apply electrical input signal to biological fluid sample.Electricity input letter Number can be current potential or electric current, can be steady state value, variable or its combination, for example apply AC signals when have DC signals skew Amount.Electrical input signal can be applied in the form of individual pulse, multiple pulses, sequence or cycle ripple.Signal generator 524 The output signal from sensor interface can be recorded and as generator-logger.
The temperature of sample in the container of the optional determination of temperature sensor 526 sensing zone 504.It can be surveyed according to output signal Amount, calculating specimen temperature, or assume that specimen temperature is the temperature with environment temperature or the device for constituting bio-sensor system Measured value it is same or like.Thermistor, thermometer or other temperature-sensing devices can be used to carry out measurement temperature.Can also Specimen temperature is determined using other technologies.
Storage medium 528 can be magnetic, optics or semiconductor memory, or other storage devices etc..Storage medium 528 Can be fixed-storage device, removable storage apparatus (such as storage card, remote access).
Processor 522 carries out analyte using computer readable software code and the data being stored in storage medium 528 Analysis and data processing.Processor 522 can be applied to biography according to presence of the sensing zone 504 at sensor interface 518, sample On sense band 504, respond user's input etc. to start analyte analyzation.The control signal generator 524 of processor 522 connects to sensor Mouth 518 provides electrical input signals.Processor 522 can receive specimen temperature from optional temperature sensor 526.Processor 522 connects Receive the output signal from sensor interface 518.Output signal is produced in response to the redox reaction of analyte in sample. Processor 522 applies in 300ms in the excitation pulse for carrying out automatic signal generator 524 measures output signal.Adopted in processor 522 Cause output signal associated with the analyte concentration of sample with one or more relational expressions.The result of analyte analyzation can be with Export to display 520, and can be stored in storage medium 528.
Allow the shapes such as the analyte concentration relational expression graphic form related to output signal, mathematical form or its combination Formula is represented.These relational expressions can be by program sequence number (PNA) table, another inquiry table for being stored in storage medium 528 etc. To represent.Instruction on performing analyte analyzation can be by the computer readable software code that is stored in storage medium 528 There is provided.Code can be description or the object code or any other code that control function described here.Can be in processor In 522 to from analyte analyzation data carry out one or more of data processing (including determine the rate of decay, k-factor, ratio Deng).
Sensor interface 518 has the contact for being connected or being electrically connected with the wire in the sample interface 514 of sensing zone 504. Sensor interface 518 sends the connection in sample interface 514 to by the electrical input signal of contact automatic signal generator in future 524 Device.Sensor interface 518 also sends the output signal from sample to processor 522 and/or signal generator by contact 524。
Display 520 can be simulation or numeral.Display can be suitable for showing that the LCD of digital reading is shown Device.
In use, the liquor sample for analysis is sent to container 508 by the way that liquid is imported into opening 512 In.Liquor sample flows through passage 510, the filling container 508 while the air that discharge had previously been included.Liquor sample is with being contained in Reagent in passage 510 and/or container 508 produces chemical reaction.
Sensing zone 504 is disposed adjacent with measurement apparatus 502.Adjacent position includes sample interface 514 and sensor interface 518 Telecommunication and/or the position of optic communication.Telecommunication is included in leading in the contact in sensor interface 518 and sample interface 514 Transmission input and/or output signal between line.Optic communication is included in optical port and sensor interface in sample interface 514 Light is transmitted between detector in 518.Optic communication is additionally included in optical port and sensor interface 508 in sample interface 514 In light source between transmit light.
Although each embodiment to the present invention is illustrated above, for ordinary skill people It is readily apparent that can have other embodiments and embodiment within the scope of the invention for member.Therefore, the present invention is removed It can not be limited outside appended claims and its equivalent limitation.
The reference of related application
This application claims submit on December 10th, 2007 it is entitled " Rapid-read Gated Amperometry's " U.S. Provisional Patent Application No.61/012729 priority, disclosure of which is incorporated herein by reference.

Claims (63)

1. a kind of handheld measuring device for being used to determine the concentration of the analyte in sample, it includes：
Sensor interface, it is applied to receive sensor strip, and the sensor interface includes at least two contacts；
At least one display；And
Circuit, it is used to set up between at least two contact and the display to be electrically connected,
Wherein, the circuit includes the signal generator and processor being electrically connected,
Wherein, the processor is electrically connected with the storage medium with computer readable software code,
Wherein, the processor is programmed to make the signal generator provide input letter between at least two contact Number,
Wherein, the input signal had at least three work period in 10 seconds, wherein, at least three work period Each includes excitation pulse and relaxation,
Wherein, the processor is programmed at least one in the signal generator applies at least three work period Described at least two are measured in 300 milliseconds of the excitation pulse of the pulse width with 0.3 to 0.8 second of individual work period At least one current value at contact, and
Wherein, the processor is programmed to determine biofluid or the biological fluids in response at least one described current value Analyte concentration in the derivative of body.
2. measurement apparatus according to claim 1, wherein, the signal generator be selected from by charger and generator- The group of logger composition.
3. measurement apparatus according to claim 2, wherein, the signal generator is charger.
4. measurement apparatus according to claim 1, wherein, the computer readable software code includes relational expression.
5. measurement apparatus according to claim 4, wherein, the relational expression be selected from by program sequence number table, inquiry table and The group of combinations thereof composition.
6. measurement apparatus according to claim 1, wherein, the processor is programmed to the momentary partial in current attenuation At least one described current value of period measurement.
7. measurement apparatus according to claim 6, wherein, the processor is programmed in response in the current attenuation The momentary partial during at least one described current value for measuring determine the biofluid or the biofluid The analyte concentration in the derivative.
8. measurement apparatus according to claim 1, wherein, the processor is programmed to from least one described work In start to count 175 milliseconds of the excitation pulse of the pulse width with 0.3 to 0.8 second in cycle described in measurement at least One current value.
9. measurement apparatus according to claim 1, wherein, the processor is programmed to at least one described current value Using at least one data processing.
10. measurement apparatus according to claim 9, wherein, at least one described data processing determines the rate of decay, K systems At least one of number and ratio value.
11. measurement apparatus according to claim 3, wherein, the processor is programmed in the charger described Measured while the input signal is provided between contact at least two contact as described in the function of time at least One current value.
12. measurement apparatus according to claim 3, wherein, the charger is programmed and at least two contact Between the input signal that provides included at least four work period in 7 seconds.
13. measurement apparatus according to claim 3, wherein, the charger is programmed and at least two contact Between the input signal that provides excited including square wave.
14. measurement apparatus according to claim 3, wherein, the charger is programmed to the voltage with substantial constant Implement the excitation pulse.
15. measurement apparatus according to claim 3, wherein, the excitation pulse that the charger is programmed and provided Pulse width be 0.3 to 0.5 second.
16. measurement apparatus according to claim 3, wherein, the excitation pulse that the charger is programmed and provided Pulse width be pulse spacing of at least one of 0.3 to 0.5 second and at least three work period be 0.7 to 2 second.
17. measurement apparatus according to claim 3, wherein, the charger is programmed and at least two contact Between the input signal that provides include the terminal read pulse of relaxation is not present below.
18. measurement apparatus according to claim 3, wherein, the processor is programmed to be provided the charger Pulse spacing of at least one of at least three work period be less than 3 seconds.
19. measurement apparatus according to claim 3, wherein, the processor is programmed to be provided the charger The relaxation include than the excitation pulse at least half of current reduction of the current reduction excited at peak.
20. measurement apparatus according to claim 3, wherein, the processor is programmed to be provided the charger The relaxation include than the excitation pulse the small at least an order of magnitude of the electric current excited at peak current reduction.
21. measurement apparatus according to claim 3, wherein, the processor is programmed to be provided the charger The relaxation include substantially zero electric current.
22. measurement apparatus according to claim 3, wherein, the processor is programmed to basis and existed by the charger The charger apply to the sample apply in 7 seconds of initial excitation pulse described at least one work period to measure State at least one current value.
23. measurement apparatus according to claim 1, wherein, the processor, which is programmed to apply in the charger, to be had The institute at least two contact is measured in have the pulse width of 0.3 to 0.8 second 60 to 150 milliseconds of the excitation pulse State at least one current value.
24. measurement apparatus according to claim 3,
Wherein, the processor is programmed to make the charger provide disconnecting circuit between at least two contact, and
Wherein, the disconnecting circuit provides the relaxation, and wherein, the relaxation is at least 0.5 second.
25. measurement apparatus according to claim 1,
Wherein, the input signal that the signal generator is provided between at least two contact can excite diffusion to hinder Measurable material in barrier, and
Wherein, the processor is programmed to substantially excluding to enter the measurable material outside the diffusion impervious layer The institute at least two contact is measured according to the measurable material in the diffusion impervious layer while row measurement State at least one current value.
26. a kind of bio-sensor system for being used to determine the analyte concentration in sample, it includes：
Sensor strip, it has the sample interface adjacent with the container formed by sensing zone；And
Measurement apparatus, it has the processor being connected with sensor interface,
Wherein, the sensor interface is electrically connected with the sample interface,
Wherein, the processor is electrically connected with storage medium,
Wherein, the processor is programmed to applying exciting with the pulse width of 0.3 to 0.8 second to the sample interface The output signal corresponding with the analyte concentration in the sample from the sensor interface is determined in 300 milliseconds of pulse Value, and
Wherein, the excitation pulse is a part for the input signal including at least three work period in 10 seconds, wherein, often The individual work period includes excitation pulse and relaxation.
27. system according to claim 26, wherein, the measurement apparatus is portable.
28. system according to claim 26, wherein, the excitation pulse has the voltage of substantial constant.
29. system according to claim 26, wherein, the processor is programmed to the momentary partial phase in current attenuation Between determine corresponding with the analyte concentration in the sample output signal value.
30. system according to claim 26, wherein, at least one work period at least three work period Pulse spacing be less than 3 seconds.
31. system according to claim 26, wherein, the pulse width of the excitation pulse is 0.3 to 0.5 second, and its In, the pulse spacing of at least one work period at least three work period is 0.7 to 2 second.
32. system according to claim 26, wherein, the relaxation includes exciting at peak than the excitation pulse At least half of current reduction of current reduction.
33. system according to claim 26, wherein, the relaxation includes exciting at peak than the excitation pulse The small at least an order of magnitude of electric current current reduction.
34. system according to claim 26, wherein, the relaxation includes the electric current being substantially zero.
35. system according to claim 26, wherein, the processor is programmed to applying institute to the sample interface State and the output signal value corresponding with the analyte concentration in the sample is determined in 60 to 150 milliseconds of excitation pulse.
36. system according to claim 26, wherein, the relaxation is at least 0.5 second, and corresponding with disconnecting circuit.
37. system according to claim 26, wherein, the sample be in biofluid and biofluid derivative extremely Few one.
38. a kind of method of the non-diagnostic purpose for the concentration for determining the analyte in sample, it includes：
Apply input signal to the sample, wherein, the input signal had at least three work period, and its in 30 seconds In, each work period at least three work period includes excitation pulse and relaxation；
300 counted the excitation pulse since at least one work period at least three work period Measurement output signal corresponding with measurable material in millisecond, wherein, the pulse width of the excitation pulse is 0.1 to 2 second；And
In response to the measured output signal, the concentration of the analyte in the sample is determined.
39. the method according to claim 38, wherein, the input signal included at least four work period in 7 seconds.
40. the method according to claim 38, wherein, the input signal included at least three work period in 10 seconds.
41. the method according to claim 38, wherein, the pulse width of the excitation pulse is 0.3 to 0.8 second.
42. the method according to claim 38, wherein, at least one work period at least three work period Pulse spacing be less than 3 seconds.
43. the method according to claim 38, wherein, the pulse width of the excitation pulse is 0.3 to 0.5 second, and its In, the pulse spacing of at least one work period at least three work period is 0.7 to 2 second.
44. the method according to claim 38, wherein, measured in being less than in 175 milliseconds of time for the excitation pulse The output signal.
45. the method according to claim 38, wherein, in 60 to 150 milliseconds counted since the excitation pulse The interior measurement output signal.
46. the method according to claim 38, it also includes：
At least one electronics is transmitted from medium of the analyte into sensing zone in the sample；And
In response to the input signal, electrochemistry is carried out to the measurable material and excited, wherein, the measurable material comes from In at least one of the analyte and the medium.
47. the method according to claim 38, wherein, the excitation pulse has the voltage of substantial constant.
48. the method according to claim 38, wherein, the input signal is excited including square wave.
49. the method according to claim 38, wherein, and in response to from a work period in the work period The excitation pulse the time for the being more than 300 milliseconds place's measurement for starting to count output signal and the analyte that determines Concentration compare, the concentration of the analyte in the sample is determined with smaller deviation.
50. method according to claim 49, wherein, with being less than the defeated of 3 work periods in response to having in 10 seconds The concentration for the analyte for entering signal and determining is compared, and the dense of the analyte in the sample is determined with smaller deviation Degree.
51. the method according to claim 38, it also includes：Recorded during the input signal is applied as time letter At least one several electric currents.
52. the method according to claim 38, it also includes：To at least one electric current of the output signal using at least One data processing, wherein, at least one described data processing determines at least one of the rate of decay, K constants and ratio value.
53. the method according to claim 38, it also includes：
Excite the measurable material in diffusion impervious layer；And
The measurable material outside the diffusion impervious layer is substantially excluded from exciting.
54. the method according to claim 38, wherein, the relaxation includes exciting at peak than the excitation pulse At least half of current reduction of current reduction.
55. the method according to claim 38, wherein, the relaxation includes exciting at peak than the excitation pulse The small at least an order of magnitude of electric current current reduction.
56. the method according to claim 38, wherein, the relaxation includes the electric current or disconnecting circuit being substantially zero.
57. method according to claim 56, wherein, the relaxation is at least 0.5 second.
58. the method according to claim 38, wherein, the determination of the concentration of the analyte is including true by transient attenuation The concentration of the fixed analyte, wherein, the output signal includes the transient attenuation.
59. the method according to claim 38, wherein, the sample be in biofluid and biofluid derivative extremely Few one.
60. the method according to claim 38, wherein, measurement is performed by handheld measuring device.
61. the method according to claim 38, wherein, the terminal that the input signal includes below in the absence of relaxation is read Pulse.
62. the method according to claim 38, wherein, it is less than 175 milliseconds what is counted since the excitation pulse Time in the measurement output signal, wherein, the excitation pulse has the pulse width of 0.3 to 0.8 second.
63. the method according to claim 38, wherein, in 60 to 150 milliseconds counted since the excitation pulse Time in the measurement output signal, wherein, the excitation pulse has the pulse width of 0.3 to 0.8 second.
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US20210148851A1 (en) 2021-05-20
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